Victoza was approved by the regulator for the treatment of type 2 diabetes in adult patients in 2010. It is now the first non-insulin drug to be approved for the indication in paediatric patients since the approval of metformin in 2000, said the FDA.
The extension of the FDA approval for the Novo Nordisk drug is based on its efficacy and safety shown in lowering blood sugar in 134 paediatric patients with type 2 diabetes in a placebo-controlled trial conducted during the treatment period of more than 26 weeks.
Nearly 64% of patients in the paediatric trial had their hemoglobin A1c (HbA1c) reduced under 7% on Victoza, in comparison to 37% recorded in the placebo arm.
Victoza improves blood sugar levels by creating identical effects in the body as the glucagon-like peptide (GLP-1) receptor protein found in the pancreas. GLP-1 is commonly found in insufficient levels in patients with type 2 diabetes.
According to FDA, the Novo Nordisk drug like GLP-1 slows digestion, stops the liver from making excessive glucose and aids the pancreas produce more insulin when required.
The regulator said that the drug is not a substitute for insulin and is not approved for treatment of type 1 diabetes or diabetic ketoacidosis.
Victoza is also indicated to lower the risk of major adverse cardiovascular events in adult patients with type 2 diabetes and established cardiovascular disease. Its effect on major adverse cardiovascular events in paediatrics is yet to be evaluated and is not indicated for the use in children.
FDA Center for Drug Evaluation and Research division of metabolism and endocrinology products acting director Lisa Yanoff said: “The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy.
“Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes. The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”